[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

[Adrian Tymes]

On Wed, Nov 27, 2013 at 12:14 PM, Dave Sill <sparge at gmail.com> wrote:

> On Wed, Nov 27, 2013 at 2:57 PM, Adrian Tymes <atymes at gmail.com> wrote:
>
>> On Wed, Nov 27, 2013 at 11:14 AM, Dave Sill <sparge at gmail.com> wrote:
>>
>>>
>>> How much risk of wrong genetic test results is acceptable to the FDA?
>>> How much does 23andMe have? Doesn't the use of a CLIA-certified lab address
>>> the quality of the results?
>>>
>>
>> Worthy questions; these items are likely in the details of the FDA's
>> communications.  Although the last one can be answered "no": it's not "do
>> you have this marker" that's the problem, but the information they attach
>> to it.
>>
>
> Ah, so if they didn't include an explanation of what the SNPs they found
> mean, then FDS would be OK? But, of course, that information is extremely
> useful.
>

If that information is correct, yes.  That is the point at issue.

And if they didn't provide that information, then for what purpose are they
providing the SNPs?  There are other purposes that could be served by just
the SNPs, true, but if it leans back toward hinting at this, the FDA would
be within its rights to crack down on that.

But we're talking about testing, not cures/treatments. The 23andMe test *cannot
> *itself be harmful--it's spitting in a tube.
>

The test itself is not the issue.  It's what's done with the results.


> At that point, I'd have to consult a physician in order to get the
> treatment, right?
>

Not necessarily.  Some such treatments are indeed "over the counter", or
even on the level of fad diets.  Not all such treatments involve pills that
can be regulated by normal means.

There's also the issue of patients convinced they need certain specific
meds that no reputable physician will give them, because said patients do
not in fact need them.  If you're convinced you need pill X but your doctor
says you do not, do you believe your doctor, or do you find other ways to
get X without seriously considering that you might be wrong?  Many people
choose the latter.

(And then there is user error, such as getting results in an email signed
with Blowfish and thinking that means they need to eat raw blowfish - which
has a significant mortality rate, but can be had without a physician in the
loop.  That's a separate issue.)
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